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FDAMay 18, 2017drug

PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of assurance of sterility: Product bags leaking at seam.

What to do

FDA enforcement status: Terminated

Brands named

sca pharmaceuticalssca

UPCs

70004081032

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32 — Recall Details · AllClear